State Rules prescribing additional qualifications for Drug Inspectors beyond Central Rules are ultra vires the Drugs and Cosmetics Act.

The U.P. Government framed the U.P. Food and Drug Administration Department Gazetted Officers (Drug) Service (Third Amendment) Rules, 2015 under Article 309 of the Constitution. Rule 8 of these Rules prescribed both academic qualifications and specific experience (18 to 36 months) as essential for the direct recruitment of Drug Inspectors.

The U.P. Public Service Commission issued advertisements in 2016 and 2018 based on these rules. The petitioners challenged the vires of Rule 8, contending that it conflicted with Rule 49 of the Drugs and Cosmetics Rules, 1945 (framed under a Central Act), which lists experience only as a condition for performing specific duties (inspecting Schedule C substances), not as an essential eligibility criterion for recruitment.

A Single Judge previously quashed the 2016 selection, leading to the Special Appeal.

1. Whether the State Government has the competence under the proviso to Article 309 to prescribe qualifications for Drug Inspectors that are inconsistent with those prescribed by the Central Government under the Drugs and Cosmetics Act, 1940.

2. Whether Rule 8(ii)(a) to (c) of the 2015 State Rules is ultra vires the Drugs and Cosmetics Act, 1940 and the Drugs and Cosmetics Rules, 1945.

The court applied the "Doctrine of Occupied Field" and the proviso to Article 309 of the Constitution, which stipulates that State-made service rules are subject to Acts of the appropriate Legislature.

Section 21 and Section 33(2)(b) of the Drugs and Cosmetics Act, 1940, which vest the power to prescribe qualifications for Inspectors exclusively in the Central Government.

The primary precedent was State of Haryana v. Krishan Kumar (2024 INSC 63), which held that when a Central Act occupies a field under Entry 19 of the Concurrent List, State rules under Article 309 cannot override Central rules.

Reference to A.B. Krishna v. State of Karnataka regarding the displacement of Executive rule-making power once the Legislature intervenes.

The court reasoned that because "Drugs and Cosmetics" falls under Entry 19 of the Concurrent List (List III), the Central Drugs and Cosmetics Act, 1940 is the dominant legislation.

Section 21(1) of the Act specifically defines "prescribed" as prescribed by rules made by the Central Government under Section 33. The court found that Rule 49 of the Central Rules, 1945, establishes the essential academic qualifications, whereas experience is merely a prerequisite for "authorization" to inspect specific substances, not a bar to recruitment itself.

By elevating this experience to an "essential qualification" in Rule 8, the State of U.P. created a conflict with Central law. Following Krishan Kumar, the court held that the State lacks the competence to legislate on qualifications in an occupied field, rendering the State’s imposition of additional restrictive criteria unconstitutional.

The court modified the Single Judge’s order to protect existing appointees but directed the Commission to allow the petitioners to apply for the 2025 selection process by waiving the restrictive experience criteria. It held that all future recruitments must strictly adhere to the qualifications prescribed by the Central Government.